Lab Tech Specialist

2 weeks ago

North York, Canada Apollo Health and Beauty Care Full time

**POSITION SCOPE**:
The Lab Technical Services (LTS) Specialist is responsible for ensuring laboratory equipment and materials are in good, working order as well as calibrated in accordance to the equipment calibration schedule. The LTS Specialist is also responsible for test method validation and tech transfer for commercial QC laboratory analytical test methods. The LTS Specialist must also be involved in out of specification and out of trend investigations covering the lab equipment functionality aspects and perform method validation and/or tech transfer deviation reporting, as necessary.

**RESPONSIBILITIES & DUTIES**:

- Supports the purchase of primary and secondary standards for laboratory analytical testing. Monitors inventory of standards and replenishes upon request.
- Strategize, coordinate and execute analytical test method validation and tech. transfer of methods from the R&D department, customers and/or external laboratories to meet the applicable internal and market regulatory standards (e.g. using ICH and USP).
- Initiates change control records, as necessary to implement test methods and procedures for lab equipment set-up and operation.
- Initiates deviation reports and investigates method validation and/or tech transfer deviations.
- Periodic review of lab methods for alignment with current ICH and USP standards.
- Performs aspects of out of specification and out of trend investigations covering the lab equipment functionality.
- Creates calibration and facility monitoring schedule for laboratory equipment and rooms (e.g. stability room).
- Performs set-up, qualification and calibration of analytical instruments. Sets up all preventative maintenance procedures for lab equipment and facilities.
- Schedules and completes the preventative maintenance activities for all lab equipment and facilities.
- Communicate with Vendors regarding:

- Reagents, standards expendables
- Planning and scheduling equipment PM/calibrations
- Manage the maintenance, calibration, and troubleshooting of laboratory equipment issues (e.g. HPLC, GC, and FTIR, etc.),
- Communicate with Maintenance and external vendors regarding the calibration of laboratory equipment as per the preventative maintenance schedule.
- Analyze calibration documents, and maintain lab tech services related SOPs to make sure they align with the current regulatory, equipment and compendia requirements.
- Training and mentoring of laboratory staff in the use of laboratory equipment.
- Perform other duties as assigned.

**JOB SPECIFICATIONS**:
**KNOWLEDGE/EDUCATION/EXPERIENCE**: 3-5 years’ laboratory experience with university or college education in science or engineering. Experience developing analytical test methods in accordance to USP and international compendia methods, and FDA/HC/ICH guidelines. Experience with technical transfer of analytical test methods. Experience working in GMP environment and deep understanding of GLP/GDP and data integrity standards in accordance to CFR Part 11 requirements. Experience with laboratory equipment calibration methodology, performing lab equipment maintenance activities, and troubleshooting HPLC, GC and FTIR equipment issues.

**INTERPERSONAL SKILLS/CONTACTS**: some access to confidential or sensitive information; some internal interactions and/or some minor external interactions; purpose of internal/external contacts is not related to complex matters; no selling, negotiating, consulting, teaching/instructing, or advising; average level of written and verbal communication skills required for successful job performance.

**PROBLEM SOLVING/JUDGMENT**: position is closely monitored and decisions follow prescribed guidelines; some analysis required; occasionally makes recommendations or referrals; responsible for solving simple to moderate technical problems.

**MENTAL EFFORT**: requires moderate to high levels of concentration and/or attentiveness; moderate duration and/or intensity of efforts; requires moderate levels of thinking, watching, listening, verifying, checking numbers, creating or designing.

**PHYSICAL EFFORT**: occasional duration or intensity of physical effort; some moderate energy required in terms of standing, walking, lifting, keyboarding, pushing, pulling, sitting, packing, assembling, bending or twisting; includes moderate fine or coarse movements.

**MATERIAL RESOURCES**: moderate level of consequence and costs associated with errors as related to losses of time, money, or property; moderate responsibility for machinery, work aids, equipment, materials, properties, products, stock, inventory or tools.

**INFORMATION RESOURCES**: moderate level of consequence and costs associated with errors as related to losses of time, money or property; moderate responsibility for information and or services; some access to confidential, sensitive or proprietary information.

**PEOPLE/POLICIES/PRACTICES**: Regular for people, policies or practices in terms of assigning work, development, evaluat

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